Prophylaxis Trial in High Risk Allogenic Stem Cell Transplant Recipients With Graft vs. Host Disease
2 other identifiers
interventional
600
0 countries
N/A
Brief Summary
This trial is in high risk patients to determine the safety, tolerance and efficacy of posaconazole (POZ) vs. fluconazole in the prophylaxis against development of invasive fungal infections (IFI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 1999
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1999
CompletedFirst Submitted
Initial submission to the registry
May 1, 2002
CompletedFirst Posted
Study publicly available on registry
May 2, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2003
CompletedMarch 10, 2017
March 1, 2017
4.1 years
May 1, 2002
March 7, 2017
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Hematopoietic progenitor cell transplant subjects with chronic or Grade II-IV acute GVHD being treated with high dose immunosuppressive therapy.
- One of the following to the subject's prior immunosuppressive regimen:
- at least 1mg per kg per day of methylprednisolone or equivalent,
- Antithymocyte globulin (ATG) for the therapy of acute GVHD,
- Tacrolimus, mycophenolate mofetil, or other steroid-sparing immunosuppressive regimen.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Ullmann AJ, Lipton JH, Vesole DH, Chandrasekar P, Langston A, Tarantolo SR, Greinix H, Morais de Azevedo W, Reddy V, Boparai N, Pedicone L, Patino H, Durrant S. Posaconazole or fluconazole for prophylaxis in severe graft-versus-host disease. N Engl J Med. 2007 Jan 25;356(4):335-47. doi: 10.1056/NEJMoa061098.
PMID: 17251530DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2002
First Posted
May 2, 2002
Study Start
January 1, 1999
Primary Completion
February 1, 2003
Study Completion
February 1, 2003
Last Updated
March 10, 2017
Record last verified: 2017-03